G1 Therapeutics and Boehringer Ingelheim Announce Commercial Availability of COSELA™ , the Only FDA-Approved Multilineage Myeloprotection Therapy to Decrease the Incidence of Chemotherapy-Induced Myelosuppression

G1 Therapeutics公司和勃林格殷格翰公司宣布Cosela™的商业化应用,这是美国FDA批准的唯一一种减少化疗诱导的骨髓抑制发生率的多系骨髓保护疗法

2021-03-03 18:31:11 BioSpace

本文共3338个字,阅读需9分钟

Launch of Innovative Therapy for People Living with Extensive-Stage Small Cell Lung Cancer is Supported by the G1 to One™ Patient Support Program, the Single Source for COSELA Access Solutions RESEARCH TRIANGLE PARK, N.C. and RIDGEFIELD, Conn., March 02, 2021 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX) and Boehringer Ingelheim today announced that COSELA™ (trilaciclib) for injection is now available in the U.S. On February 12, 2021, the U.S. Food and Drug Administration (FDA) approved COSELA to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). It is the first and only therapy designed to help protect bone marrow (myeloprotection) when administered prior to treatment with chemotherapy. “This is an exciting time for the combined G1 and Boehringer Ingelheim team as we are now able to provide COSELA, the first proactive multilineage myeloprotection therapy, to patients with extensive-stage small cell lung cancer,” said Soma Gupta, Chief Commercial Officer at G1 Therapeutics. “Our commitment includes ensuring excellence in support and access to COSELA; to that end, we are excited to launch the G1 to One Patient Support Program which is designed to provide access and affordability solutions to eligible patients.” “We are proud to help bring COSELA to the physicians and their patients who are in need of options when it comes to managing ES-SCLC treatment,” said Dan Asch, Head of Commercial Oncology at Boehringer Ingelheim Pharmaceuticals, Inc. “G1’s experienced and passionate commercial and medical teams along with Boehringer Ingelheim’s seasoned oncology team are eager to engage with the community to communicate the clinical benefits of this innovative therapy.” “Because ES-SCLC cannot be cured, the goals of treatment are increased life expectancy and improved quality of life; most patients prioritize quality of life, but clinicians have very few tools to do this,” said Jared Weiss, MD, Associate Professor of Medicine, Division of Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina Chapel Hill, NC. “Chemotherapy can result in potentially debilitating side effects, many of which are hematologically driven, such as severe low white blood cell counts (neutropenia) and anemia, which can cause fatigue. Doctors accept these side effects because we lack tools to help prevent them. COSELA (trilaciclib) provides the first proactive approach to help protect against myelosuppression through a unique mechanism of action that helps proactively protect the bone marrow from damage when given prior to chemotherapy.” Chemotherapy is an effective and important weapon against cancer. However, chemotherapy does not differentiate between healthy cells and cancer cells. It kills both, including important hematopoietic stem and progenitor cells (HSPCs) in the bone marrow that produce white blood cells (immune cells that help fight infection), red blood cells (cells that carry oxygen from the lungs to the tissues), and platelets (cells that prevent bleeding from cancer, surgeries, chronic diseases, and injuries). Chemotherapy-induced bone marrow damage, known as myelosuppression, can lead to increased risk of infection, anemia, thrombocytopenia, and other complications. Myeloprotection is a novel approach to protect HSPCs in the bone marrow from chemotherapy-induced damage. This approach can help reduce some chemotherapy-related toxicities, which helps make chemotherapy safer and more tolerable, while also reducing the need for reactive rescue interventions. COSELA is available through the following specialty distributors: Amerisource Specialty Distribution, Oncology Supply, McKesson Plasma and Biologics, McKesson Specialty and Cardinal Specialty. COSELA is expected to be widely covered by insurance plans. The G1 to One™ Patient Support Program offers a suite of solutions to address common access and reimbursement challenges, such as benefits verification for patient coverage and out-of-pocket costs. The program provides payor-specific guidance for prior authorizations and appeals to address patient needs; offering solutions for insurance-related delays and connecting patients, regardless of insurance type, to appropriate resources that can address high deductibles, co-pays/co-insurance, or lack of coverage when certain eligibility requirements are met. For more information, patients and providers can call G1 to One at 833-G1toONE (833-418-6663) from 8:00 AM to 8:00 PM Eastern time. About COSELA™ (trilaciclib) COSELA™ (trilaciclib) is the first and only myeloprotection therapy to help decrease the incidence of chemotherapy-induced myelosuppression. Administered intravenously as a 30-minute infusion within four hours prior to the start of chemotherapy, COSELA helps proactively deliver multilineage myeloprotection to patients with extensive-stage small cell lung cancer (ES-SCLC) being treated with chemotherapy. COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC. For more information about COSELA visit www.cosela.com. COSELA (trilaciclib) Co-Promotion Agreement with Boehringer Ingelheim In June 2020, G1 announced a three-year co-promotion agreement with Boehringer Ingelheim for COSELA in small cell lung cancer in the U.S. and Puerto Rico. G1 will lead marketing, market access and medical engagement initiatives for COSELA. The Boehringer Ingelheim oncology commercial team, well-established in lung cancer, will lead sales force engagement initiatives. G1 will book revenue and retain development and commercialization rights to COSELA and pay Boehringer Ingelheim a promotional fee based on net sales. The three-year agreement does not extend to additional indications that G1 is evaluating for trilaciclib. Press release details of the G1/Boehringer Ingelheim agreement can be found here. About Small Cell Lung Cancer In the U.S., approximately 30,000 small cell lung cancer patients are treated annually. SCLC, one of the two main types of lung cancer, accounts for about 10% to 15% of all lung cancers. SCLC is an aggressive disease and tends to grow and spread faster than NSCLC. It is usually asymptomatic; once symptoms do appear, it often indicates that the cancer has spread to other parts of the body. About 70% of people with SCLC will have cancer that has metastasized at the time they are diagnosed. The severity of symptoms usually increases with increased cancer growth and spread. From the time of diagnosis, the general five-year survival rate for people with SCLC is 6%. The five-year survival rates for limited-stage (the cancer is confined to one side of the chest) SCLC is 12% to 15%; and for extensive stage (ES; cancer has spread to the other lung and beyond), survival rates are less than 2%. Chemotherapy is the most common treatment for ES-SCLC. COSELA™ (trilaciclib) for Injection INDICATION COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). IMPORTANT SAFETY INFORMATION CONTRAINDICATION COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib. WARNINGS AND PRECAUTIONS Injection-Site Reactions, Including Phlebitis and Thrombophlebitis COSELA administration can cause injection-site reactions, including phlebitis and thrombophlebitis, which occurred in 56 (21%) of 272 patients receiving COSELA in clinical trials, including Grade 2 (10%) and Grade 3 (0.4%) adverse reactions. Monitor patients for signs and symptoms of injection-site reactions, including infusion-site pain and erythema during infusion. For mild (Grade 1) to moderate (Grade 2) injection-site reactions, flush line/cannula with at least 20 mL of sterile 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP after end of infusion. For severe (Grade 3) or life-threatening (Grade 4) injection-site reactions, stop infusion and permanently discontinue COSELA. Injection-site reactions led to discontinuation of treatment in 3 (1%) of the 272 patients. Acute Drug Hypersensitivity Reactions COSELA administration can cause acute drug hypersensitivity reactions, which occurred in 16 (6%) of 272 patients receiving COSELA in clinical trials, including Grade 2 reactions (2%). Monitor patients for signs and symptoms of acute drug hypersensitivity reactions. For moderate (Grade 2) acute drug hypersensitivity reactions, stop infusion and hold COSELA until the adverse reaction recovers to Grade ≤1. For severe (Grade 3) or life-threatening (Grade 4) acute drug hypersensitivity reactions, stop infusion and permanently discontinue COSELA. Interstitial Lung Disease/Pneumonitis Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with cyclin-dependent kinases (CDK)4/6 inhibitors, including COSELA, with which it occurred in 1 (0.4%) of 272 patients receiving COSELA in clinical trials. Monitor patients for pulmonary symptoms of ILD/pneumonitis. For recurrent moderate (Grade 2) ILD/pneumonitis, and severe (Grade 3) or life-threatening (Grade 4) ILD/pneumonitis, permanently discontinue COSELA. Embryo-Fetal Toxicity Based on its mechanism of action, COSELA can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use an effective method of contraception during treatment with COSELA and for at least 3 weeks after the final dose. ADVERSE REACTIONS Serious adverse reactions occurred in 30% of patients receiving COSELA. Serious adverse reactions reported in >3% of patients who received COSELA included respiratory failure, hemorrhage, and thrombosis. Fatal adverse reactions were observed in 5% of patients receiving COSELA. Fatal adverse reactions for patients receiving COSELA included pneumonia (2%), respiratory failure (2%), acute respiratory failure (<1%), hemoptysis (<1%), and cerebrovascular accident (<1%). Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received COSELA. Adverse reactions leading to permanent discontinuation of any study treatment for patients receiving COSELA included pneumonia (2%), asthenia (2%), injection-site reaction, thrombocytopenia, cerebrovascular accident, ischemic stroke, infusion-related reaction, respiratory failure, and myositis (<1% each). Infusion interruptions due to an adverse reaction occurred in 4.1% of patients who received COSELA. The most common adverse reactions (≥10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia. DRUG INTERACTIONS COSELA is an inhibitor of OCT2, MATE1, and MATE-2K. Co-administration of COSELA may increase the concentration or net accumulation of OCT2, MATE1, and MATE-2K substrates in the kidney (e.g., dofetilide, dalfampridine, and cisplatin). To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see full Prescribing Information here. For more information about COSELA, please call 1-800-790-G1TX (1-800-790-4189) or visit www.cosela.com. About G1 Therapeutics G1 Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the discovery, development and delivery of next generation therapies that improve the lives of those affected by cancer, including the Company’s first commercial product, COSELA™ (trilaciclib). G1 has a deep clinical pipeline evaluating targeted cancer therapies in a variety of solid tumors, including colorectal, breast, lung, and bladder cancers. G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics. G1 Therapeutics™ and the G1 Therapeutics logo, COSELA™ and the COSELA logo, G1 to One™ and the G1 to One logo are trademarks of G1 Therapeutics, Inc. About Boehringer Ingelheim in Oncology Cancer takes. Takes away time. Takes away loved ones. At Boehringer Ingelheim Oncology, we are giving patients new hope, by taking cancer on. We are dedicated to collaborating with the oncology community on a shared journey to deliver leading science. Our primary focus is in lung and gastrointestinal cancers, with the goal of delivering breakthrough, first-in-class treatments that can help win the fight against cancer. Our commitment to innovation has resulted in pioneering treatments for lung cancer and we are advancing a unique pipeline of cancer cell directed agents, immuno-oncology therapies and intelligent combination approaches to help combat many cancers. About Boehringer Ingelheim Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good. As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of around $21.3 billion (19 billion euros). Our significant investment of over $3.9 billion (3.5 billion euros) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life. We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come. Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies. In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA. Boehringer Ingelheim is committed to improving lives and strengthening our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives. For more information, please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to, COSELA’s (trilaciclib) possibility to improve patient outcomes, COSELA may fail to achieve the degree of market acceptance for commercial success, and are based on the company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the company’s filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the company’s dependence on the commercial success of COSELA; the development and commercialization of new drug products is highly competitive; the company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Contact: Will Roberts G1 Therapeutics, Inc. Vice President, Investor Relations and Corporate Communications (919) 907-1944 wroberts@g1therapeutics.com
为广泛期小细胞肺癌患者推出的创新疗法得到了G1到One™患者支持计划的支持,这是COSELA Access解决方案的单一来源 北卡罗来纳州研究三角公园。康涅狄格州里奇菲尔德,2021年3月02日(环球新闻通讯社)--G1 Therapeutics,Inc.(Nasdaq:GTHX)和勃林格殷格翰公司今天宣布,注射用COSELA™(trilaciclib)现已在美国上市。2021年2月12日,美国食品和药物管理局(FDA)批准了COSELA可降低成人患者在广泛期小细胞肺癌(ES-SCLC)的含铂/足叶乙甙方案或含拓扑替康方案之前使用的化疗诱导的骨髓抑制的发生率。它是第一种也是唯一一种在化疗前使用的帮助保护骨髓(骨髓保护)的疗法。 G1治疗公司首席商务官索玛·古普塔说:“对于G1和勃林格殷格翰联合团队来说,这是一个激动人心的时刻,因为我们现在能够为广泛期小细胞肺癌患者提供第一种积极的多谱系骨髓保护疗法COSELA。“我们的承诺包括确保出色地支持和利用COSELA;为此,我们很高兴推出G1到One患者支持计划,该计划旨在为符合条件的患者提供可获得的、负担得起的解决方案。“ 勃林格殷格翰制药公司的商业肿瘤学主管丹·阿施说:“我们很自豪能帮助将COSELA带给那些在管理ES-SCLC治疗时需要选择的医生和患者。G1公司经验丰富、充满激情的商业和医疗团队以及勃林格殷格翰公司经验丰富的肿瘤学团队渴望与社区合作,交流这种创新疗法的临床益处。” “由于ES-SCLC无法治愈,治疗的目标是延长预期寿命和改善生活质量;北卡罗来纳大学教堂山分校Lineberger综合癌症中心肿瘤学部医学副教授Jared Weiss博士说:“大多数病人都把生活质量放在首位,但临床医生很少有工具来做到这一点。”“化疗可能导致潜在的虚弱的副作用,其中许多是血液驱动的,如严重的低白细胞计数(中性粒细胞减少症)和贫血,这会导致疲劳。”医生接受这些副作用是因为我们缺乏帮助预防它们的工具。COSELA(trilaciclib)提供了第一个通过一种独特的作用机制帮助预防骨髓抑制的主动方法,这种作用机制在化疗前给予时有助于主动保护骨髓免受损伤。“ 化疗是对抗癌症的有效而重要的武器。然而,化疗并不能区分健康细胞和癌细胞。它会杀死这两种细胞,包括骨髓中重要的造血干细胞和祖细胞(HSPCs)。这些细胞产生白细胞(帮助抵抗感染的免疫细胞)、红细胞(将氧气从肺输送到组织的细胞)和血小板(防止癌症、手术、慢性疾病和损伤出血的细胞)。化疗引起的骨髓损伤,称为骨髓抑制,可导致感染、贫血、血小板减少和其他并发症的风险增加。骨髓保护是一种保护骨髓中HSPCs免受化疗损伤的新方法。这种方法可以帮助减少一些化疗相关的毒性,这有助于使化疗更安全、更可耐受,同时也减少了反应性抢救干预的需要。 COSELA可通过以下专业分销商获得:Amerisource专业分销、肿瘤供应、麦克森血浆和生物制品、麦克森专业和Cardinal专业。COSELA预计将被保险计划广泛覆盖。 G1到One™患者支持计划提供了一套解决方案,以解决常见的获取和报销挑战,如患者覆盖范围的福利验证和自付成本。该计划为事先授权和上诉提供付款人特定的指导,以满足患者的需求;为与保险相关的延误提供解决方案,并将患者(无论保险类型如何)连接到适当的资源,以解决高免赔额、共同支付/共同保险或在满足某些资格要求时缺乏承保范围的问题。如需更多信息,患者和提供者可在美国东部时间上午8:00至晚上8:00拨打G1对1电话833-G1toOne(833-418-6663)。 关于科塞拉·™(trilaciclib) Cosela™(trilaciclib)是第一种也是唯一一种帮助降低化疗诱导的骨髓抑制发生率的骨髓保护疗法。COSELA在化疗开始前4小时内静脉给药,每次30分钟,可帮助广泛期小细胞肺癌(ES-SCLC)化疗患者主动提供多系骨髓保护。在治疗ES-SCLC之前使用含铂/足叶乙甙的方案或含拓扑替康的方案时,COSELA可降低成人患者化疗诱导的骨髓抑制的发生率。 欲了解更多关于COSELA的信息,请访问www.COSELA.com。 COSELA(trilaciclib)与勃林格殷格翰共同推广协议 2020年6月,G1宣布与勃林格殷格翰公司达成一项为期三年的联合推广协议,用于在美国和波多黎各治疗小细胞肺癌的COSELA。G1将领导COSELA的市场营销、市场准入和医疗参与倡议。勃林格殷格翰肿瘤学商业团队在肺癌领域有很好的经验,将领导销售团队的参与活动。G1将向COSELA记账收入并保留开发权和商品化权,并根据净销售额向勃林格殷格翰支付促销费。这份为期三年的协议并不适用于G1正在为Trilaciclib进行评估的其他迹象。G1/Boehringer Ingelheim协议的新闻稿详情可在此找到。 关于小细胞肺癌 在美国,每年大约有30,000名小细胞肺癌患者接受治疗。SCLC是肺癌的两种主要类型之一,约占所有肺癌的10%至15%。SCLC是一种侵袭性疾病,往往比NSCLC生长和传播更快。通常是无症状的;一旦症状确实出现,往往表明癌症已经扩散到身体其他部位。大约70%的小细胞肺癌患者在被诊断时会有转移的癌症。症状的严重程度通常随着癌症生长和扩散的增加而增加。从诊断时起,SCLC患者的一般五年生存率为6%。局限期(局限于一侧胸部)小细胞肺癌的5年生存率为12%~15%;而对于广泛期(ES;癌症已经扩散到其他肺或更远),存活率不到2%。化疗是ES-SCLC最常见的治疗方法。 注射用柯赛拉™(trilaciclib) 指示 在治疗广泛期小细胞肺癌(ES-SCLC)时,在使用含铂/足叶乙甙的方案或含拓扑替康的方案之前使用COSELA可降低成人患者化疗诱导的骨髓抑制的发生率。 重要安全信息 禁忌证 对Trilaciclib有严重超敏反应史的患者禁用COSELA。 警告和注意事项 注射部位反应,包括静脉炎和血栓性静脉炎 COSELA给药可引起注射部位反应,包括静脉炎和血栓性静脉炎,临床试验中272例接受COSELA的患者中有56例(21%)发生,包括2级(10%)和3级(0.4%)不良反应。监测患者注射部位反应的体征和症状,包括输液部位疼痛和输液过程中的红斑。对于轻度(1级)至中度(2级)注射部位反应,输液结束后用至少20毫升无菌的0.9%氯化钠注射液或5%葡萄糖注射液冲洗管路/套管。对于严重的(3级)或危及生命的(4级)注射部位反应,停止输液并永久停用Cosela。注射部位反应导致272例患者中3例(1%)中断治疗。 急性药物超敏反应 COSELA给药可引起急性药物超敏反应,临床试验中272例接受COSELA的患者中有16例(6%)发生,包括2级反应(2%)。监测患者急性药物超敏反应的体征和症状。对于中度(2级)急性药物超敏反应,停止输液,持有COSELA,直至不良反应恢复至≤1级。对于严重(3级)或危及生命(4级)的急性药物超敏反应,停止输液,永久停用COSELA。 间质性肺病/肺炎 严重的、危及生命的或致命的间质性肺疾病(ILD)和/或肺炎可发生在接受COSELA等细胞周期蛋白依赖性激酶(CDK)4/6抑制剂治疗的患者中,临床试验中272例接受COSELA治疗的患者中有1例(0.4%)发生。监测ILD/肺炎患者的肺部症状。对于反复发作的中度(2级)ILD/肺炎,以及严重(3级)或危及生命(4级)的ILD/肺炎,永久停用COSELA。 胚胎-胎儿毒性 根据其作用机制,COSELA给孕妇服用时会对胎儿造成伤害。有生殖潜力的女性在使用COSELA治疗期间以及在最后剂量后至少3周内应使用有效的避孕方法。 不良反应 30%接受COSELA的患者出现严重不良反应。在接受COSELA治疗的患者中,严重的不良反应包括呼吸衰竭、出血和血栓形成。 5%的接受COSELA的患者观察到致命的不良反应。使用COSELA的患者的致命不良反应包括肺炎(2%)、呼吸衰竭(2%)、急性呼吸衰竭(<1%)、咯血(<1%)、脑血管意外(<1%)。 接受Cosela治疗的患者中有9%因不良反应而永久停药。导致接受COSELA治疗的患者永久停止任何研究治疗的不良反应包括肺炎(2%)、乏力(2%)、注射部位反应、血小板减少、脑血管意外、缺血性中风、输液相关反应、呼吸衰竭和肌炎(各<1%)。 在接受Cosela治疗的患者中,有4.1%的患者因不良反应而中断输液。 最常见的不良反应(≥10%)为乏力、低钙血症、低钾血症、低磷血症、天冬氨酸转氨酶升高、头痛、肺炎。 药物相互作用 COSELA是OCT2、MATE1和Mate-2K的抑制剂。共同给药COSELA可能增加OCT2、MATE1和MATE-2K底物在肾脏中的浓度或净蓄积(例如多非利特、达法普定和顺铂)。 若要报告疑似不良反应,请联系G1 Therapeutics公司(电话:1-800-790-G1TX)或FDA(电话:1-800-FDA-1088)或www.FDA.gov/medwatch。 请在此查看完整的处方信息。 欲了解更多关于COSELA,请致电1-800-790-G1TX(1-800-790-4189)或访问www.COSELA.com。 关于G1疗法 G1 Therapeutics,Inc.是一家商业阶段的生物制药公司,专注于发现、开发和提供改善癌症患者生活的下一代疗法,包括该公司的第一个商业产品Cosela™(trilaciclib)。G1有一个深入的临床管道,评估各种实体肿瘤的靶向癌症疗法,包括结直肠癌、乳腺癌、肺癌和膀胱癌。G1治疗公司总部设在北卡罗来纳州的研究三角公园。欲了解更多信息,请访问www.g1therapeutics.com并在Twitter@g1therapeutics上关注我们。 G1 Therapeutics™和G1 Therapeutics徽标、COSELA™和COSELA徽标、G1 to One™和G1 to One徽标是G1 Therapeutics公司的商标。 Boehringer Ingelheim在肿瘤学中的应用 癌症需要。浪费时间。带走所爱的人。在勃林格殷格翰肿瘤科,我们给了病人新的希望,通过接受癌症治疗。我们致力于与肿瘤学社区的合作,在一个共同的旅程,以提供领先的科学。我们的主要重点是肺癌和胃肠道癌症,目标是提供突破性的、一流的治疗方法,以帮助赢得与癌症的斗争。我们对创新的承诺导致了肺癌的开创性治疗,我们正在推进一条独特的癌细胞导向剂、免疫肿瘤疗法和智能组合方法的管道,以帮助对抗多种癌症。 勃林格殷格翰简介 为人类和动物制造新的更好的药物是我们工作的核心。我们的使命是创造改变生活的突破性疗法。勃林格殷格翰公司自1885年成立以来,一直是独立的家族企业。我们可以自由地追求我们的长远愿景,展望未来,以确定未来的健康挑战,并针对那些我们可以做最有益的工作的需要领域。 作为一家全球领先、以研究为导向的制药公司,超过51000名员工每天通过创新为我们的三个业务领域创造价值:人类制药、动物健康和生物制药合同制造。2019年,勃林格殷格翰实现了约213亿美元(190亿欧元)的净销售额。我们在研发方面投入了超过39亿美元(35亿欧元)的巨额投资,推动了创新,使下一代药品能够拯救生命和提高生活质量。 我们通过拥抱生命科学界合作伙伴关系和专家多样性的力量来实现更多的科学机会。通过共同努力,我们将加速实现下一个医疗突破,这将改变现在和未来几代人的生活。 勃林格殷格翰制药公司位于康涅狄格州里奇菲尔德,是勃林格殷格翰公司在美国最大的子公司,也是勃林格殷格翰公司集团的一部分。此外,还有位于佐治亚州德卢斯的勃林格殷格翰动物健康公司和位于加利福尼亚州弗里蒙特的勃林格殷格翰弗里蒙特公司。 勃林格殷格翰致力于改善生活和加强我们的社区。请访问www.boehringer-ingelheim.us/csr了解更多关于企业社会责任倡议的信息。 欲了解更多信息,请访问www.boehringer-ingelheim.us,或在Twitter@boehringerus上关注我们。 前瞻性陈述 本新闻稿包含1995年私人证券诉讼改革法案含义范围内的前瞻性陈述。诸如“可能”、“将”、“预期”、“计划”、“预期”、“估计”、“打算”等词语和类似的表述(以及其他提及未来事件、条件或情况的词语或表述)旨在识别前瞻性陈述。本新闻稿中的前瞻性陈述包括但不限于,COSELA(trilaciclib)改善患者结局的可能性,COSELA可能无法达到商业成功的市场接受程度,以及基于截至本新闻稿发布之日公司的预期和假设。这些前瞻性陈述中的每一项都涉及风险和不确定性。可能导致公司实际结果与本新闻稿中前瞻性陈述中明示或暗示的结果不同的因素在公司向美国证券交易委员会提交的文件中进行了讨论,包括其中包含的“风险因素”部分,并包括但不限于公司对Cosela商业成功的依赖;新药产品的开发和商业化竞争激烈;公司完成其任何候选产品的临床试验、获得批准和商业化的能力;公司在正在进行的临床试验中的初步成功可能并不表明这些试验完成或在后期试验中获得的结果;与开发新产品或新技术以及作为发展阶段公司经营相关的固有不确定性;和市场状况。除法律要求外,公司没有义务更新本文中包含的任何前瞻性陈述,以反映预期的任何变化,即使有新的信息可用。 联系人: 威尔·罗伯茨 G1治疗公司。 副总裁,投资者关系及公司传讯部 (919)907-1944 电子邮件:wroberts@g1therapetics.com

以上中文文本为机器翻译,存在不同程度偏差和错误;偶尔因源网页结构局限,内容无法一次完整呈现。请理解并参考原站原文阅读。

阅读原文